The following data is part of a premarket notification filed by Neuro Diagnostics, Inc. with the FDA for Ndi-ike Emg.
| Device ID | K801670 |
| 510k Number | K801670 |
| Device Name: | NDI-IKE EMG |
| Classification | Conditioner, Signal, Physiological |
| Applicant | NEURO DIAGNOSTICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GWK |
| CFR Regulation Number | 882.1845 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-07-22 |
| Decision Date | 1980-08-04 |